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    FDA 510(k) FDA class 1 Substantially Equivalent 🇹🇼 Taiwan

    MAXHEALTH MECHANICAL WHEELCHAIR, K1

    K Number: K070176 · Decision Mar 1, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    129
    Registration Numbers
    129
    Same Product Code
    458
    Applicant Total
    2
    Review Days
    42

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    Basic Information

    Device Name
    MAXHEALTH MECHANICAL WHEELCHAIR, K1
    K Number
    K070176
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.3850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Maxhealth Corp.
    Date Received
    January 18, 2007
    Decision Date
    March 1, 2007
    Product Code
    IOR
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    IOR Wheelchair, Mechanical

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    Other Clearances by Maxhealth Corp.

    K Number Device Name
    K001252 MAXHEALTH WHEELCHAIR, MODEL HE-8631, HE-8621, HE-8651